The FDA is delaying implementation of last year's rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively.
The agency will now give priority reviews to new generic drugs until there are 3 on the market.
Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred.
Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.
Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.
The drug is indicated for treating patients with locally advanced or metastatic disease that progresses despite platinum-containing chemotherapy.
After analyzing new data, the FDA again warns that the diabetes drug may be associated with an increased risk for bladder cancer.
Updated label for patiromer now recommends the drug be taken at least 3 hours before or after other oral medications.
The new FDA warning alerts prescribers to the abuse potential of testosterone.
Labeling changes will alert prescribers to the abuse potential of testosterone and the serious adverse effects.
Labeling information will include data showing the drug reduces the risk of radiographic progression versus bicalutamide.
While ADFs of opioids may help mitigate the risk of opioid abuse, they have limitations as well.
Once-daily injection to improve glycemic control, along with diet and exercise.
Fluoroquinolones such as Cipro, Levaquin should be reserved for life-threatening infections.
The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.
Calcifediol formulation is indicated for CKD stage 3 or 4 patients with secondary hyperparathyroidism associated with vitamin D insufficiency.
The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).
The FDA has developed 2- and 10-year goals to reduce sodium content in both processed and prepared foods.
Added sugars, relevant portion sizes among the highlights of revision.
Atezolizumab received accelerated FDA approval for patients whose disease has progressed despite platinum-based chemotherapy.
Agency is recommending that health care providers not prescribe them for certain patients.
Many believe meds supported by stronger evidence than the law requires to achieve designation.
The diabetes drug was contraindicated due to the risk of lactic acidosis.
Drugs containing saxagliptin or alogliptin may be linked to heart failure risk.
New labeling rules require immediate-release opioids to carry warnings for the serious risk for misuse.
Agency aims to improve treatment of pelvic organ prolapse.
National blood surveillance system will help agency ensure safety of the blood supply.
Drug found to limit worsening of the disease and reduce the need for hospitalization.
Nivolumab is cleared for treating patients with metastatic RCC whose disease advanced despite prior treatment with anti-angiogenic therapy.
Patiromer for oral suspension lowers potassium levels in hyperkalemic patients with chronic kidney disease.
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